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NCT04457752
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.
NCT01782989
This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).
NCT03423212
Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care. This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
NCT02483078
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance.
NCT02421159
The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)). HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample. The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn. The supplement study hypotheses are: (H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience. (H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN. (H3): Most participants (\> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase. (H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (\> 70%), all of whom will be HIV infected, will be linked to care within 3 months.
NCT02562469
A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).
NCT02801266
This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.
NCT05087576
The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment.
NCT02299492
This proposed study addresses the problem of service disengagement within the mental health system. No matter how effective mental health practices are now or become in the future, they are of little value should persons with mental illnesses continue to choose not to receive them. Consumers have attributed their disengagement from care to having poor alliances with care providers, including experiences of not being listened to and not being offered the opportunity to make decisions and collaborate in their own treatment. Person-centered care planning is a field-tested intervention designed to maximize consumer choice and ownership of the treatment process. Providers collaborate with consumers to develop customized plans that identify life goals and potential barriers to achieving them. The proposed study tests the effectiveness of Person-Centered Care Planning (PCCP) designed to target barriers and efficiently implement PCCP throughout an agency. By conducting a randomized controlled trial with 14 community mental health clinics from two states, the study will assess whether PCCP improves service engagement and consumer outcomes. The study will also utilize qualitative methods to understand how care planning impacts service engagement and how implementation processes influence organizational and provider level behavior. Designed to bridge the science to services gap, this study focuses on two priorities identified by the NIMH Diversion of Services and Intervention Research: developing models and methods to implement effective mental health services in the community and the study of personalized mental health care.
NCT02670902
This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.
NCT01099449
RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.
NCT05601063
Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.
NCT02987153
Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or potentially unstable spinal cord metastases. The primary objective is to evaluate the response rate of pain control when combining kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90 days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral compression fracture
NCT02046135
The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows: 1\. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
NCT04450394
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.
NCT03479398
This project compares two methods of assessing the quality of cognitive behavioral therapy (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in clinical notes, and 2) rating the quality of worksheets that are completed with therapist guidance during sessions. It also examines whether ratings of worksheets completed on a mobile app are reliable and valid quality measures. This information can inform strategies to monitor and enhance CBT quality, which can ultimately improve the quality of care and clinical outcomes.
NCT03920254
A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157
NCT04006964
The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.
NCT04051944
The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
NCT03452293
The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.